A Single Arm, Open Label, Dose-escalation Phase I and Dose-expansion Phase IIa Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Allogeneic Chimeric Antigen Receptor (CAR) Gamma-Delta T Cells CAR001 in Subjects with Relapsed/refractory Solid Tumors
This study is composed of phase I and IIa parts. The dose-escalation phase I part aims to find the maximum tolerated dose (MTD) and to identify the safety of CAR001 in subjects with relapsed/refractory solid tumor; the dose-expansion phase IIa part aims to evaluate the potential efficacy of CAR001 in subjects with relapsed/refractory non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) or Glioblastoma multiforme (GBM).
• Male or female subjects aged ≥ 18 years
• For phase I part, subjects with histologically confirmed diagnosis of solid tumor with expression of PD-L1 ≥ 1% and are relapsed/refractory to at least two lines of standard-of-care therapy. For phase IIa part, subjects with histologically confirmed diagnosis of TNBC, NSCLC, CRC or GBM with expression of PD-L1 ≥ 1%, and are relapsed/refractory to at least two lines of standard-of-care therapy.
• With at least one measurable lesion as defined by RECIST1.1 (for TNBC, NSCLC or CRC) or RANO (for GBM)
• Able to understand and sign the ICF
• Have a life expectancy of \> 12 weeks
• ECOG performance status ≤ 1
• Recovered from any previous therapy related toxicity to ≤ grade 2 at screening
• With adequate renal function: serum creatinine ≤ 1.5 X ULN; eGFR \> 50 ml/min
• With adequate liver function: ALT, AST, and ALP ≤ 3X ULN or ≤ 5 X ULN if liver metastases; and total bilirubin ≤ 1.5X ULN or ≤ 3 X ULN if due to Gilbert's disease
⁃ With PT and PTT ≤ 1.5X ULN
⁃ With adequate hematopoietic function:
∙ ANC ≥ 1,000 cells/μl
‣ Platelets ≥ 75,000 counts/μl
‣ Total WBC ≥ 2,000 cells/μl
‣ Hemoglobin ≥ 8 g/dL